uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.

uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.

uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

u WS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

Device Description

The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.

The uCT ATLAS is a multi-slice computed tomography scanner that features the following specification and technologies.

160 mm z-coverage in a single axial exposure with a 320-row 0.5 mm-slice Z-• Detector
. 0.25 s rotation speed for high temporal resolution, and maximum 440 mm/s fast volumetric scanning capability
. 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible positioning and access for all patients
. The new generation reconstruction method. Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time improving low contrast detectability and spatial resolution
. The uAI Vision patient positioning assistance
Built upon these technologies, the uCT ATLAS is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the whole organ coverage and fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.

The uWS-CT-Dual Energy Analysis is a software package that uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria or a detailed study proving that a device meets those criteria. The document is a 510(k) premarket notification summary for the uCT ATLAS with uWS-CT-Dual Energy Analysis system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria.

While the document mentions "Performance Verification" and "Clinical Image Evaluation of applications," and states that "The testing results show that all the software specifications have met the acceptance criteria," it does not provide:

A table of acceptance criteria and reported device performance.
Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for test sets.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Specifics about the type of ground truth used or how ground truth for training sets was established.

The document states that "No Clinical Study is included in this submission," which further indicates that the detailed information you're requesting regarding clinical performance studies isn't present in this specific FDA submission summary.

The closest information available is:

Non-Clinical Testing: Includes dosimetry and image performance tests, and conformance to various electrical safety, EMC, and product particular standards (e.g., NEMA XR 25-2019, IEC 61223-3-5). The acceptance criteria for these would be compliance with the specified standards, but the specific performance values are not detailed.
Software Verification and Validation: Mentions that "all the software specifications have met the acceptance criteria," but does not list those criteria or performance results.

In summary, the provided document focuses on regulatory clearance through substantial equivalence, indicating that the device has similar performance and safety as legally marketed predicate devices. It does not contain the detailed performance study information you are seeking.

Summary

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August 11, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.

Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No. 2258 Chengei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA

Re: K203448

Trade/Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 12, 2021 Received: July 15, 2021

Dear Xin Gao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

. for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203448

Device Name

uCT ATLAS with uWS-CT-Dual Energy Analysis

Indications for Use (Describe)

uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern in design.

510 (K) SUMMARY

K203448

1. Date of Preparation November 18, 2020

Sponsor Identification 2.

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Contact Person: Xin GAO Position: RA Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com

3. Identification of Proposed Device

Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Common Name: Computed Tomography X-ray System Model(s): uCT ATLAS

Regulatory Information

Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

4. Identification of Predicate/Reference Device(s)

Predicate Device

510(k) Number: K172135 Device Name: uCT 760, uCT 780 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

Reference Device #1

510(k) Number: K161009 Device Name: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray and has a white vertical line running through the center, creating a negative space effect.

Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK

Reference Device #2

510(k) Number: K193073 Device Name: Deep Recon Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK

Reference Device #3

510(k) Number: K132813 Device Name: DUAL ENERGY SYSTEM PACKAGE Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK

Reference Device #4

510(k) Number: K120833 Device Name: DISCOVERY CT750 HD Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK

ട്. Device Description:

The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.

The uCT ATLAS is a multi-slice computed tomography scanner that features the following specification and technologies.

160 mm z-coverage in a single axial exposure with a 320-row 0.5 mm-slice Z-• Detector
. 0.25 s rotation speed for high temporal resolution, and maximum 440 mm/s fast volumetric scanning capability
. 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible positioning and access for all patients
. The new generation reconstruction method. Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern, and the colors are muted.

improving low contrast detectability and spatial resolution

. The uAI Vision patient positioning assistance
Built upon these technologies, the uCT ATLAS is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the whole organ coverage and fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.

6. Indications for Use

The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes a CT System and a software package.

uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.

Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

uWS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy

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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in bold. The color of the text and the "U" shape is a dark teal.

Analysis software combines images acquired with low and high energy spectra to visualize this information.

7. Comparison of Technological Characteristics with the Predicate/Reference Devices

The uCT ATLAS with uWS-CT-Dual Energy Analysis has the same intended use as the predicate device uCT 760, uCT 780.

The proposed device includes more technology/features, which is discussed in the following chapters, than the predicate device. These differences will not impact the safety and effectiveness of the device.

ITEM	Proposed Device	Predicate DeviceuCT 760, uCT 780(K172135)	Remark
Specifications
Gantry	●160mm DetectorRotation speed:up to0.25s/rotation●82cm bore	●40mm DetectorRotation speed: upto 0.35s/rotation(uCT 760); up to0.3s/rotation (uCT780)●70cm bore	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
Patient Table	Max. load capacity318kg	Max. load capacity 205kg	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
Reconstruction Fieldof View	40mm-500mm40mm-600mm withextend FOV	40mm-500mm	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
Maximum slicesgenerated perrotation	640	uCT 760:128uCT 780:160	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
Functions
Low Dose CT LungCancer ScreeningProtocol	Yes	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
uAI Vision -EasyPositioningEasyISO	Yes,	--	Substantially Equivalent
	It's a patientpositioning assistancefunction based on deeplearning technology	--	The changes did not raise newsafety and effectivenessconcerns.
Auto ALARA kVp	YesIt can recommend thesuitable kVp for theexamination.	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
Organ-Based AutoALARA mA	YesIt can optimize thedose modulation forthe combined chestand abdomen scanwith deep learningbased organrecognition.	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
CardioXphase	YesIt can recommend theoptimal phase forcardiac reconstructionwith less motionartifact.	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
CardioCapture	YesIt can reduce thecoronary motionartifact with deeplearning basedcoronary arteryextraction.	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
EasyRange	YesIt can automaticallyrecommend the scanrange with a deeplearning organrecognitiontechnology	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
Injector Linkage	Yes	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.
Remote Assistance	Yes	--	Substantially EquivalentThe changes did not raise newsafety and effectivenessconcerns.

Table 1 Comparisons to Predicate Device

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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal.

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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue and has a white vertical line running through the center. The logo is simple and modern in design.

Item	Proposed device	Reference device #1Aquilion ONE VisionWith FIRST 2.0(CCRS-001B) V7.4(K161009)	Reference device #2Deep Recon(K193073)	Discussion ofdifferences
AnatomicalRegion	Abdomen, pelvis,chest	Abdomen, pelvis,chest, cardiac andextremities	Abdomen, pelvis,chest, cardiac andhead	Same
Exposure DoseReduction	Yes	Yes	Yes	Same
QuantitativeDose ReductionClaim	Yes	Yes	Yes	Same
Image QualityImprovementClaim	Yes	Yes	Yes	Same
ReconstructionTechnology	It is an imagereconstructionmethod thatcombines amodal-basediterativereconstructionand deep learningtechnology.	It is an iterativereconstructionalgorithm.	Dedicated deep neuralnetwork (DNN) whichis trained on low doseFBP images to getnormal dose (highquality) FBP images	SubstantiallyEquivalentTesting did notraise new safetyand effectivenessconcerns.

Table 3 Dual Energy comparison to Reference Devices

Item	ProposedDevice	Reference device #3Dual Energy SystemPackage (K132813)	Reference device #4Discovery CT750 HD(K120833)	Discussion ofdifferences
Dual Energy Scan	Yes	Yes	Yes	Same
Dual Energy Analysis
Mono Energetic Image	Yes	Yes	--	Same
Mixed Enhanced Image	Yes	Yes	--	Same
CNR(Contrast Noise Ratio)Image	Yes	Yes	--	Same
Water-Iodine Base MaterialPair	Yes	--	Yes	Same
Water-Calcium BaseMaterial Pair	Yes	--	Yes	Same
Calcium-Iodine BaseMaterial Pair	Yes	--	Yes	Same
Uric acid-Calcium BaseMaterial Pair	Yes	--	Yes	Same
Image Registration	Yes	Yes	--	Same
Effective Atomic NumberImages	Yes	--	Yes	Same
Electron Density Image	Yes	--	Yes	Same

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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray. The logo is simple and modern in design.

Virtual Non contrast Images	Yes	--	Yes	Same
Component analysis ofkidney stones, uric acidstones or non-uric acidstones	Yes	Yes	--	Same
Component analysis of jointgout, uric acid gout or non-uric acid gout	Yes	Yes	--	Same

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

Non-clinical testing including dosimetry and image performance tests were conducted for the uCT ATLAS with uWS-CT Dual Energy Analysis during the product development.

UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uCT 760/780 in accordance with the following standards:

A ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsIEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008). Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

Product Particular Standards

NEMA XR 25-2019, Computed Tomography Dose Check A
A NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT
NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment - Part 1-3:

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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark gray with a white vertical line running through the center.

General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-ray Equipment

A IEC 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)]

Performance Verification

A Performance Evaluation Report for the functions
A Clinical Image Evaluation of applications

Software

NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine A (DICOM)
A IEC 62304: Medical Device Software - software life cycle process
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Biocompatibility

ISO 10993-5 Third Edition 2009-06-01. Biological Evaluation Of Medical > Devices - Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

Other Standards and Guidances

A ISO 14971: Medical Devices - Application of risk management to medical devices
Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

Software Verification and Validation

Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.

The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have

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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is divided vertically into two halves, with a horizontal line connecting the two halves in the upper portion of the "U". The logo is simple and modern in design.

met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.

UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.

Clinical Testing

No Clinical Study is included in this submission.

Summarv

The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT ATLAS with uWS-CT Dual Energy Analysis was found to have a safety and effectiveness profile that is similar to the predicate device.

9. Conclusions

Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety, and effetiveness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety, and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.